CN102791207B - Make the calcified material in cardiac valve broken - Google Patents

Abstract

A kind of device of the calcified material fragmentation made in cardiac valve, comprise and be assembled in delivery system (10) and go up and pass through expansible regulator (14) that delivery system (10) launches and expansible impacter arm (20), wherein, delivery system (10) can operate to make the impacter arm (20) in expanded position mobile relative to regulator (14) with enough energy, thus the calcified material making to be arranged in the tissue be sandwiched between regulator (14) and impacter arm (20) is broken.

Description

Breaks up calcium deposits in heart valves

technical field

The present invention generally relates to devices and methods for disrupting calcifications in leaflets of heart valves, such as aortic valves.

Background technique

Essential to normal heart function are four heart valves that allow blood to flow in the correct direction through the four chambers of the heart. Valves have two or three cusps, valves, or leaflets, which consist of fibrous tissue attached to the wall of the heart. The cusps open when blood flow is flowing properly and then close to form a tight seal to prevent backflow.

The four chambers of the heart are known as the right and left atria (upper chambers) and the right and left ventricles (lower chambers). The four valves that control blood flow are known as the tricuspid, mitral, pulmonary, and aortic valves. In a properly functioning heart, the tricuspid valve allows deoxygenated blood to flow in one direction from the upper right heart chamber (right atrium) to the right lower chamber (right ventricle). When the right ventricle contracts, the pulmonary valves allow blood to flow from the right ventricle to the pulmonary artery, which delivers deoxygenated blood to the lungs. The mitral valve allows oxygenated blood that has returned to the upper left chamber of the heart (left atrium) to flow to the lower left chamber of the heart (left ventricle). When the left ventricle contracts, oxygenated blood is pumped through the aortic valve into the aorta.

Certain heart abnormalities arise from defects in heart valves, such as narrowing or calcifications. This involves calcium buildup in the valve, which hinders the normal movement of the valve leaflets.

Contents of the invention

The present invention seeks to provide improved devices and methods that can be used to disrupt calcifications in aortic valve leaflets to increase leaflet softness and mobility, whether as monotherapy, bypass therapy, or for transcatheter valve implantation. Entry into the "landing zone" preparation.

The term "crushing" refers to any type of reduction in size or any change in shape or form, such as, but not limited to, crushing, pulverizing, cracking, grinding, chopping, and the like.

According to an embodiment of the present invention there is provided a device for fracturing calcifications in a heart valve, comprising a catheter comprising an outer shaft in which an expandable stabilizer is disposed, an impactor shaft on which an expandable arm is mounted, and an inner shaft, wherein the inner shaft is movable to cause the impactor arms to expand outward and locked in the expanded shape, and wherein the impact element is movable to cause the impactor arms in the expanded shape to move toward the tissue with sufficient energy to thereby Calcifications located in the tissue held by the stabilizer in a specific position facing the impactor arm are broken up.

According to a non-limiting embodiment of the present invention, the impact element includes an inner shaft connected to the distal portion of the impactor arm and operable to move relative to the impactor shaft to expand the impactor arm outward and apply sufficient energy The impactor arm in the expanded configuration is caused to move towards the stabilizer. The inner shaft can be locked relative to the striker shaft, thereby securing the striker arm.

According to a non-limiting embodiment of the invention, the impact element comprises a weight and biasing means, wherein the biasing means urges the weight towards the impactor arm with sufficient energy. In one example, the weight is mounted on a biasing device secured to the distal tip of the catheter. In another example, the weight is fixed to the inner shaft of the catheter. In yet another example, the biasing device includes a source of pneumatic energy connected to a source of pressurized gas.

According to a non-limiting embodiment of the invention, the stabilizer comprises a stabilizer structure comprising one or more (of any form or shape, such as a rod, ring, or more) optionally covered by a stabilizer cover. components of complex structures). The stabilizer may include a stabilizer structure covered by a covering bladder. An inflation/deflation tube can be inserted into the cover bladder. A first pressure sensor may be positioned near the stabilizer (in the portion of the catheter located in the aorta), while a second pressure sensor may be located near the impactor arm (in the portion of the catheter located in the LVOT or left ventricle). For cross-top use, the device can be designed in a "reverse" fashion, so that the impactor is proximal and the stabilizer can be positioned at the distal end of the device. The stabilizer arms can expand outward from the outer shaft.

Description of drawings

The present invention will be more fully understood and appreciated from the following detailed description taken in conjunction with the accompanying drawings, in which:

Figure 1 is a simplified illustration of the anatomy of the calcified aorta, ascending aorta, and aortic arch.

Figure 2 is an enlarged view of a calcified aortic valve.

3 is a simplified illustration of the distal portion of an impactor catheter system that may be used to disrupt aortic valve calcifications, constructed and operative in accordance with a non-limiting embodiment of the present invention.

FIG. 4 is a simplified illustration of several shafts coming out proximally of the catheter of FIG. 3 .

Figure 5 is a device for breaking up calcifications in a heart valve using a weight according to another non-limiting embodiment of the present invention.

5A and 5B are simplified illustrations of a weight before impact and after impact, respectively.

6 and 6A are simplified illustrations of a device for breaking up calcifications in a heart valve with a weight, according to yet another non-limiting embodiment of the present invention.

7-10C are simplified illustrations of several types of stabilizers that can be used to effectively position the distal portion of the device, hold a portion of the leaflet in place during impact, and Reacts to the ventricular impact applied to the valve leaflets.

11 is a simplified illustration of an impactor arm having more than one arm facing each leaflet, according to a non-limiting embodiment of the invention.

12 is a simplified illustration of an impactor catheter that optimally preserves valve function during surgery while allowing continuous measurement of the blood pressure gradient between the left ventricle and the aorta, according to a non-limiting embodiment of the present invention.

13 is a simplified illustration of a transapical configuration of a device for delivering shocks to calcified valve leaflets, according to a non-limiting embodiment of the invention.

14 and 15 are simplified illustrations of impactor catheters based on a pneumatic energy source on the proximal side of the catheter and a weight pull impact mechanism on the distal portion, according to a non-limiting embodiment of the invention.

16A-16D are simplified illustrations of an impactor device constructed and operative in accordance with another non-limiting embodiment of the present invention.

Figure 17 is a simplified illustration of the distal end of the device of Figures 16A-16D showing the positioning and vibrating elements in an open state.

18A and 18B are diseased tricuspid heart valves in which the diseased leaflets have calcified lesions.

19A-19I are simplified illustrations of a method of using the device of FIGS. 16A-16D according to another non-limiting embodiment of the invention.

Figure 20 is a simplified illustration of the positioning elements of the device with a net attached thereto to capture any debris that may be generated as part of the process.

21A and 21B are simplified illustrations of another embodiment in which the positioning element is an inflatable pad or bladder.

Figure 22A shows a longitudinal section through the aortic wall with a fracture line created by the impactor at the centerline of the leaflet.

Figure 22B is a radiograph of a typical valve leaflet after a single fragmentation near its centerline.

Detailed ways

Reference is now made to Figure 1, which illustrates the anatomy of a calcified aortic valve, ascending aorta, and aortic arch. The calcifications may be embedded in the valve leaflets, which attach to the aortic wall just below the coronary opening.

Reference is now made to Figure 2, which is an enlarged view of a calcified aortic valve. The valve leaflets form a concave sinus just below the coronary ostia on its aortic aspect. Calcifications can become embedded in the leaflets, making them thicker and less supple. Specifically, calcifications that develop at the base of the leaflets, where they attach to the annulus or artery wall, can significantly impair leaflet mobility, similar to friction on a door hinge.

Reference is now made to FIG. 3, which is a distal portion of an impactor catheter system useful for disrupting calcified aortic valves, constructed and operative in accordance with a non-limiting embodiment of the present invention.

Catheter 10 may be delivered through a guide wire 11 using a retrograde approach through a blood vessel, such as a peripheral artery, through the aortic arch and into the ascending aorta just above the aortic valve. At this stage, all catheter components are still covered by the outer catheter shaft 12 . The outer shaft 12 is then retracted, thereby opening the expandable (eg, self-expanding) stabilizer 14 connected to the stabilizer shaft 16 . The stabilizer 14 is used to guide, position and anchor the distal portion of the catheter in the sinus just above the valve leaflets. Note that catheter 10 is only one example of a delivery system for delivering and operating the stabilizer described below and the impactor arm for impacting calcifications. Alternatively, the stabilizer and impactor arms described below may be delivered and/or operated by means other than catheters, such as leads or lead and push/pull systems.

The impactor shaft 18, including the impactor arm 20, is then pushed forward (toward the distal side) through the center of the valve and into the left ventricle. When pushed forward, the impactor arms 20 are folded so that they can easily pass through the valve. The inner shaft 22 connected to the distal portion of the impactor arms 20 is then pulled proximally to cause the impactor arms 20 to move laterally outwardly to open (expand) and lock them in the expanded shape. The impactor shaft 18 and inner shaft 22 are then pulled back (proximally) a little so that the impactor arm 20 makes good contact with the ventricular aspect of the leaflet so that the leaflet is "clamped" against the proximally positioned stabilizer 14 (from above in the figure) and the distally positioned impactor arm 20 (from below in the figure). To break up the leaflet calcifications, while the stabilizer 14 holds the relevant portion of the leaflet in place, the valve is passed at a speed of at least 1 m/sec (such as but not limited to about 5-20 m/sec) but with at least 0.5 mm An amplitude such as, but not limited to, about 0.5-3 mm pulls the impactor shaft 18 and inner shaft 22 to abruptly pull the impactor arm 20 toward the leaflet tissue, breaking up the calcifications without injuring the soft tissue.

Reference is now made to FIG. 4 , which shows a plurality of shafts coming out proximally of the catheter 10 shown in FIG. 3 . The overall operation of catheter 10 is accomplished by controlling the relative positions of these shafts. For example, as shown in FIG. 3 , the inner shaft 22 is pulled relative to the striker shaft 18 to open the striker arm 20 . The inner shaft 22 and striker shaft 18 lock together, thereby securing the striker arm 20 . In order to create an effective impact at the distal portion of the catheter, the inner/impactor shaft 22/18 is suddenly drawn together against the valve leaflet tissue with the stabilizer shaft 16 fixed. This sudden pull at the proximal side is transferred to the distal portion.

Reference is now made to Figure 5, which illustrates an alternative mechanism for generating an impact at the distal portion of the catheter. The weight 24 is mounted on a biasing means 26, such as a coil spring, which is secured to a distal tip 28 of the catheter. Prior to impact ( FIG. 5A ), weight 24 is pushed toward distal tip 28 , thereby retracting biasing device 26 . To generate an impact, the weight 24 is released so that the biasing device 26 can accelerate the weight 24 until the weight 24 strikes the impactor arm 20 (FIG. 5B). The impactor arm 20 in turn impacts the calcified leaflet. In order to maximize the impact velocity of the impactor arm 20 for a given specific momentum of the accelerating weight 24, the mass of the impactor arm 20 may be reduced. This can be done by choosing an impactor shaft 18 that is also spring-like, minimizing the propulsion of the impactor shaft 18, or by allowing the impactor arm 20 to "float" and move freely relative to the rest of the catheter during impact without friction. partially realized.

Reference is now made to Figure 6, which illustrates another alternative mechanism for generating an impact at the distal portion of the catheter. A weight 24A (which may be the end of the catheter) is fixed to the inner shaft 22 of the catheter (in this configuration the impactor arm 20 is not attached to the inner shaft 22). Prior to impact, the inner shaft 22 is pushed distally so that the weight 24A moves a certain distance away from the impactor arm 20 (which may be a few millimeters to a few centimeters). To generate an impact, the weight 24A is now accelerated proximally until it strikes the impactor arm 20 at high speed. A biasing device 26A (a version of which is shown in FIG. 6A ), a pneumatic mechanism, or any other mechanism may be used to generate the required acceleration of the mass. The advantage of this method over that described in FIGS. 3-4 is that when the energy source is external, it is easier to generate a high voltage at the distal portion of the catheter by using a more powerful biasing device or energy source. rate.

Reference is now made to FIGS. 7-10, which illustrate various types of stabilizers that can be used to effectively position the distal portion of the catheter relative to the valve anatomy, or position portions of the valve leaflets during impact. Stays in place and reacts to the ventricular impact applied to the valve leaflets. It is desirable to maximize the reaction force on the aortic aspect of the leaflet during impact while ensuring that the stabilizer surface is sufficiently compliant and blunt to minimize damage to the leaflet surface.

Reference is now made to FIG. 7 which shows a stabilizer structure 30 which may take the form of one or more rings (e.g., at least one ring fits into each sinus above the valve leaflets, two for a mitral aortic valve). one or more, and three or more for the tricuspid aortic valve). The stabilizer structure 30 is (optionally) covered by a stabilizer cover 32, which may be a thin metal mesh (mesh), a solid plastic surface, or the like. If the stabilizer cover 32 is solid, or if the stabilizer cover is based on a mesh with sufficiently small pores, the stabilizer cover 32 can be used as an embolic protection device, i.e., at the end of the shock procedure, should any embolic , these emboli can then be safely collected into the catheter when using the external shaft folded stabilizer.

Reference is now made to FIG. 8 , which shows an alternative stabilizer design that integrates a cover bladder 34 on each stabilizer structure 30 . Each bladder 34 is elongated and its central axis follows the curvature of the rings making up the stabilizer structure 30 . The ring may also serve as an inflation/deflation tube for the air bag, wherein fluid for inflation passes through one or more inflation/deflation openings 36 . A great advantage of a balloon-based stabilizer is that the stabilizer can be positioned in the sinus by deflation of the balloon. The balloon 34 can then be inflated to create sufficient contact with the leaflet surface to maximize impact reaction forces while avoiding trauma.

Reference is now made to FIG. 9, which shows another design of an airbag-based stabilizer. Each of the three covering bladders 34 covers one of the stabilizer structural rings 30 . An inflation/deflation tube 38 may be inserted into each balloon proximally thereof. FIG. 10A shows a top view of the airbag 34 . 10B and 10C show side views of the deflated and inflated balloon 34, respectively.

Reference is now made to Fig. 11, which shows another configuration of impactor arm 20 comprising a plurality of arms facing each valve. It is readily understood that the number and geometry of the impactor arms is based on the optimal location of the leaflets one wishes to impact, such as the number and orientation of impact lines, points or areas per leaflet, closer to the leaflet base Or the impact of the end, etc.

Reference is now made to Figure 12, which illustrates the configuration of an impactor catheter that optimally preserves valve function during surgery while allowing continuous measurement of the blood pressure gradient between the left ventricle and the artery. The impactor arm 20 and stabilizer structure 30 contact the leaflet only at its base, ie near the annulus, where heavily calcified leaflets are usually immobile. The leaflet tips remain free to move so that overall valve function is little disturbed by the device as the device delivers shocks. Two pressure sensors, a first pressure sensor 40 above the valve (closer to the stabilizer) and a second pressure sensor 42 below the valve (closer to the impactor arm), measure arterial and ventricular blood pressure, respectively. This allows continuous measurement of the pressure gradient across the valve, which can be used as real-time feedback that is very important to the success of the procedure. In addition to integrating pressure sensors in the device, one can design a sufficiently large tubing in the catheter with a distal opening at each region of interest where pressure needs to be measured and can be connected to a pressure sensor outside the patient's body. Proximal port of the sensor.

Reference is now made to Figure 13, which illustrates a trans-apical configuration of a device for delivering shocks to calcified valve leaflets. Similar elements are labeled similarly as above. The transapical approach, although more aggressive than the transfemoral approach, allows the device to be rigid and short, thereby potentially improving impact from the proximal (outer) portion of the device to its distal portion. Delivery of the impactor arm. The stabilizer 14 is positioned closer to the distal tip 44 of the device. The tip 44 must first pass through the valve and open the stabilizer 14 to position the device, hold some portion of the leaflet and react to the impact.

Reference is now made to Figures 14 and 15, which illustrate one embodiment of an impactor catheter based on a pneumatic energy source on the proximal side of the catheter and a weight-pull impact mechanism on the distal portion. Again, like elements are labeled like above.

Reference is now made to Figure 14, which shows the distal end of the catheter. A catheter is delivered into the valve through a guide wire 11 . The outer sheath (shaft) 12 is retracted to expose the stabilizer arms 50 which expand outwardly from the outer shaft 12 . (The stabilizer arm 50 extends from the stabilizer shaft 51 shown in Figure 15.) The catheter is then advanced distally until the stabilizer arm 50 is in sufficient contact with the aortic aspect of the valve leaflet. The impactor is then advanced through the center of the valve (via lead 11) into the LVOT (left ventricular outflow tract).

This embodiment includes an impactor arm 52 which is preferably, but not necessarily, cut from a Nitinol tube and pre-formed generally half-open. The distal ends (or a common distal end) of the impactor arms 52 are fixed (eg, welded) to an inner tube (shaft) 54 which is free to move back and forth within the impactor tube (shaft) 18 . As the inner tube 54 is drawn proximally by the operator on the proximal side of the catheter, the impactor arms 52 extend laterally, increasing the impactor diameter. As inner tube 54 is pushed distally, impactor arm 52 closes or reduces its diameter. Changing the relative position of the inner tube 54 with respect to the impactor shaft 18 allows the operator to set the optimal impactor diameter during the procedure each time the valve is treated. Furthermore, this allows the operator to select the area on the calcified leaflet to be impacted. Another option shown in this embodiment is to be able to rotate the impactor relative to (or with) the stabilizer and the valve leaflets to impact other (or different) areas on the valve leaflets. In setting the impactor arm diameter and angular position, these settings can now be locked by the user (by locking the position of the inner tube 54 in the operator's hand on the control side of the catheter). Now, the impactor is gently pulled until the impactor is in sufficient contact with the ventricular side of the leaflet and at the same time is locked in the longitudinal position.

The weight 24 can be pulled proximally by means of the weight pull shaft 56 as described above.

Reference is now made to FIG. 15 , which shows the proximal side of the impactor catheter depicted in FIG. 14 . A source of pneumatic energy 58 (which acts as a biasing device) is connected to a source of pressurized air (working chamber wall inlet, compressor, air bladder, etc.). The body of the pneumatic energy source 58 is preferably connected to the stabilizer shaft 51 to react the impact applied to the valve leaflets on the distal portion of the catheter. As shown in FIG. 14 , the longitudinal position of the inner shaft 54 relative to the striker shaft 18 as well as the longitudinal and angular positions of the striker shaft 18 are set and locked by the user. The weight/pull shaft 56 is now pushed to the most distal position and is then connected to the piston 62 and the proximal mass 64 . Piston 62 is arranged to slide within a master cylinder 66 which houses a pneumatic valve 68 and is open to air from an air container 70 through an air inlet 72 . When pneumatic valve 68 is opened by the operator, pressurized air in air container 70 is released to master cylinder 66 through air inlet 72, thereby rapidly accelerating piston 62 and proximal mass 64 over a distance. Piston 62 and proximal mass 64 acquire relatively high energy (momentum) while pulling on weight/pull shaft 56 connected to distal weight 24 at the tip of the catheter. Upon reaching a certain distance of travel, the distal weight 24 strikes the impactor arm 52, which then transfers energy to the valve calcifications to form a fragment. Use of a weight/pull mechanism allows high impact energy to be delivered through the flexible conduit.

Reference is now made to FIGS. 16A-16D , which illustrate an impactor device 100 according to another non-limiting embodiment of the present invention. The device 100 comprises an outer sheath 101 in which one or more positioning elements 102 and one or more (radially) vibrating (shocking) elements 103 are arranged. The device 100 has a tip 104 that allows the device to be guided through the ventricle by the lead 11 . 16A to 16D illustrate the gradual retraction of the outer sheath 101 and the opening of the positioning element 102 . FIG. 16D shows the radial opening of the vibrating element 103 .

The vibration mechanism is an active device that can be made to move in and out in a radial direction at a frequency and amplitude determined by the operator or preset by the manufacturer. The inner vibratory mechanism vibrates against the inner side of the native leaflet, while the positioning element has been positioned earlier, thereby exerting a force at the designated location, and provides resistance to said force. The effect obtained changes the structure of the calcifications within the valve leaflets.

The vibration mechanism may be configured as a tube with an axially cut slit around its outer circumference. If the tube is compressed such that its ends move towards each other, the material between the circumferentially cut slits will extend radially outward (element 103).

Referring now to FIG. 17, FIG. 17 shows the distal end of the device 100 with the positioning member 102 and the vibrating member 103 respectively in their open positions. Note that vibrating elements 103 may be distributed uniformly or non-uniformly around the periphery of device 100 .

Figures 18A and 18B show a diseased tricuspid heart valve, diseased leaflets with calcified lesions. The opening of the valve (Fig. 18B) was adversely affected by calcifications.

Reference is now made to FIGS. 19A-19I , which illustrate treatment of a diseased valve using the device. Lead wire 11 is introduced into the artery and advanced until the distal end of the wire passes through the valve leaflets. In the case of an aortic valve, the lead 11 will be advanced until the distal end of the lead is within the left ventricle. The device 100 is advanced through the lead 11 until the distal end of the device is at or near the valve annulus. The outer sheath 101 is partially withdrawn, exposing the positioning mechanism, the element 102 of which extends radially outwards. The device 100 is moved in the distal direction (in the case of the aortic valve, towards the left ventricle) so that the positioning element 102 rests against the pocket between the downstream surface of the leaflet and the aortic wall. Device 100 may be turned slightly to facilitate proper positioning of element 102 .

Once in position, the vibrating mechanism actively expands radially so that the vibrating element 103 rests against the inner or downstream surface of the valve leaflets. It is possible to pre-tension the vibrating element 103 against the leaflet so as to remain stretched against the leaflet tissue, which is sandwiched between the positioning element 102 and the vibrating element 103 .

The operator can now initiate an oscillating movement of the element 103 whereby repetitive forces are applied to the inner surface of the leaflet thereby effecting a structural change of the calcifications formed in the leaflet tissue.

Reference is now made to Figure 20 which shows a positioning element 102 having a mesh 105 attached thereto to capture any debris that may be generated as part of the process. The mesh can be distributed around the positioning element 102 and can be made from a wide range of suitable materials.

Reference is now made to Figures 21A and 21B, which illustrate another possible embodiment in which the positioning element 102 is an inflatable cushion or bladder. The bladder is usually filled with a fluid such as saline and provides the counterforce needed to resist the force generated by the vibrating mechanism. The balloon is inflated in such a way that it does not block the opening of the coronary arteries.

Figure 22A shows a longitudinal incision through the aortic wall with a fracture line formed by an impactor (eg, having three impact arms) at the centerline of each leaflet. Similarly, any number and pattern of fragmentation may be preset or implemented. Figure 22B is a radiograph of a typical valve leaflet after a single fragmentation near its centerline.

The scope of the present invention includes combinations and subcombinations of the features described above as well as modifications and variations thereof which would occur to a person skilled in the art after reading the above description and which are not in the prior art.

Claims (14)

1. A device for disrupting calcification in a heart valve comprising: An expandable stabilizer (14) and an expandable impactor arm (20) assembled on and deployed by a delivery system (10), wherein the delivery system (10) is operable to The impactor arm (20) in the expanded position moves relative to the stabilizer (14) such that tissue sandwiched between the stabilizer (14) and the impactor arm (20) The calcification in is broken up, and wherein said delivery system (10) comprises catheter, and said expandable stabilizer (14), inner shaft (22) and impactor shaft (18) are arranged in said catheter, and said impactor A striker arm (20) is mounted on the striker shaft (18), and wherein the inner shaft (22) is movable to cause the striker arm (20) to expand outwardly and be locked in an expanded shape, and wherein The impact member (18, 24) is movable to cause the impactor arm (20) in the expanded configuration to move relative to the stabilizer (14) with sufficient energy such that 14) The calcification in the tissue between the impactor arm (20) is broken. 2. The device according to claim 1, wherein said percussion element comprises said inner shaft (22), said inner shaft (22) being connected to a distal portion of said impactor arm (20), and said The inner shaft (22) is operable to move relative to the striker shaft (18) to expand the striker arm (20) outwardly with sufficient energy to cause the striker arm (20) in the expanded configuration to ) towards the stabilizer (14). 3. The device according to claim 1, wherein the inner shaft (22) is lockable relative to the striker shaft (18), thereby securing the striker arm (20). 4. The device according to claim 1, wherein said sufficient energy is associated with moving said impactor arm (20) towards said stabilizer (14) at a speed of at least 1 m/sec and an amplitude of at least 0.5 mm couplet. 5. The device of claim 1, wherein the impact element comprises a weight (24, 24A) and a biasing device (26, 26A), wherein the biasing device (26) applies sufficient energy to the A weight (24) pushes towards said impactor arm (20). 6. The device according to claim 5, wherein said weight (24) is mounted on said biasing means (26), said biasing means (26) being fixed to the distal tip (28) of said catheter ). 7. The device according to claim 5, wherein said weight (24A) is fixed to said inner shaft (22) of said catheter. 8. The device of claim 1, wherein the stabilizer comprises a stabilizer structure (30) covered by a stabilizer cover (32). 9. The device of claim 1, wherein the stabilizer comprises a stabilizer structure (30) covered by a covering bladder (34). 10. The device according to claim 9, wherein an inflation/deflation tube (38) is inserted into the covering bladder (34). 11. The device according to claim 1, further comprising a first pressure sensor (40) located in the vicinity of the stabilizer (14) and a second pressure sensor (42) located in the vicinity of the impactor arm (20) ). 12. The device of claim 1, wherein the stabilizer (14) is located remotely from the impactor arm (20). 13. The device of claim 1, wherein the stabilizer comprises outwardly expandable stabilizer arms (50). 14. The device of claim 5, wherein the biasing device comprises a pneumatic energy source (58) connected to a pressurized gas source (60).